Deal Ignites Ignyta, ESPR Surges On Study Results, MCUR Ahead Of Timeline

(RTTNews) - Aldeyra Therapeutics Inc. (ALDX) has opened enrollment for its phase II clinical trial of NS2 for patients with Sjögren-Larsson Syndrome. The company expects the trial to begin enrollment in the first half of 2015, with preliminary data expected by the end of the year.

Sjögren-Larsson Syndrome is a rare disease caused by mutations in fatty acid aldehyde dehydrogenase that lead to severe ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease.

ALDX closed Tuesday's trading at $11.11, down 3.05%.

Celldex Therapeutics Inc. (CLDX) has entered into a clinical trial collaboration with Roche to evaluate the safety, tolerability and preliminary efficacy of Varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a phase 1/2 study in renal cell carcinoma.

Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin this year.

CLDX closed Tuesday's trading at $30.23, down 2.39%.

Esperion Therapeutics Inc.'s (ESPR) phase 2b study evaluating the efficacy and safety of its drug candidate ETC-1002 against placebo in patients with hypercholesterolemia on stable statin therapy has met the primary endpoint of significant reduction in LDL-cholesterol.

According to the trial results, ETC-1002-treated patients achieved 17 and 24 percent incremental reductions in LDL-cholesterol at doses of 120 mg and 180 mg, respectively, compared with patients on stable statin therapy alone.

ESPR touched a new high of $100.50 on Tuesday before closing the day's trading at $99.60, up 29.18%.

Five Prime Therapeutics Inc. (FPRX) was down more than 7% in extended trading on Tuesday after the company reported a wider loss for the fourth quarter and full year ended December 31, 2014.

Looking ahead, the company has a number of events lined up for this year.

A phase 1a/1b trial evaluating the company's drug candidate FPA008 with Bristol-Myers Squibb's (BMY) *Nivolumab is expected to begin by mid-2015. Five Prime and Bristol-Myers plan to explore the combination in patients with non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma.

*Bristol-Myers' Nivolumab was approved under the FDA's accelerated approval program as Opdivo, last December.

A phase 1/2 clinical trial of FPA008 in PVNS (pigmented villonodular synovitis), an orphan indication, is expected to begin by mid-2015. The company anticipates that preliminary efficacy data from the phase 1 portion of this trial could be available by the end of 2015 or early 2016.

A phase I clinical trial of FPA008 in rheumatoid arthritis patients with active disease who are on methotrexate is underway, and preliminary open-label data are expected to be available by the end of 2015.

FPRX closed Tuesday's trading 3.27% higher at $25.90. In after-hours, the stock was down 7.18% to $24.04.

Ignyta Inc. (RXDX) is acquiring Teva Pharmaceutical Industries Ltd.'s (TEVA) assets and worldwide rights relating to four oncology development programs in exchange for 1.5 million shares of Ignyta's common stock.

Concurrently, Ignyta has entered into stock purchase agreements with Teva, and selected additional healthcare investors, whereby Teva will purchase a further 1.5 million shares of common Ignyta stock at a price of $10 per share in a registered direct offering. The other investors will purchase an additional 2.7 million shares at $10 per share, valuing the total offering at approximately $41.6 million.

RXDX closed Tuesday's trading at $7.92, up 5.60%. In after-hours, the stock gained over 26% to $10.00.

Macrocure Ltd. (MCUR) expects data from an ongoing pivotal phase III, randomized, double-blind, sham controlled clinical trial of its lead product candidate, CureXcell, in diabetic foot ulcer in October 2015.

CureXcell is a combination of living human white blood cells that have been activated to facilitate the healing process and stimulate wound closure.

The results from a pivotal, phase III trial of CureXcell in Venous Leg Ulcer patients are now expected to be available in the first half of 2016, earlier than the initial timeline of the second half of 2016.

Macrocure went public on The NASDAQ Global Market on July 31, 2014, priced at $10.00 per share.

MCUR closed Tuesday's trading at $9.47, up 1.50%.